On March 6, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported the presentation of emerging oncology pipeline data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting April 5-10 in San Diego (Press release, BeiGene, MAR 6, 2024, View Source [SID1234640871]). BeiGene has nine abstracts scheduled for poster presentations at AACR (Free AACR Whitepaper).

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"Our presentations at this year’s AACR (Free AACR Whitepaper) showcase our ongoing development of tislelizumab combinations in solid tumors as we assess the clinical potential of multiple novel immuno-oncology candidates and make data-driven decisions for further development," said Lai Wang, Ph.D., Global Head of Research & Development at BeiGene. "More broadly, they reflect our deep commitment to discovering innovative new medicines for cancer patients, including by pioneering novel mechanisms like targeted degradation."

BeiGene will present results from the AdvanTIG-204 Phase 2 study of tislelizumab (anti-PD1) plus ociperlimab (anti-TIGIT) in first-line limited-stage small cell lung cancer (SCLC) as well as results of a biomarker study of the same doublet in the setting of first-line non-small cell lung cancer (NSCLC). An ongoing, global Phase 3 trial of ociperlimab plus tislelizumab in stage IV, PD-L1 high NSCLC, AdvanTIG-302, will complete enrollment this month (NCT04746924). An additional clinical presentation includes the first data from a Phase 1a dose escalation study of BGB-10188, a phosphatidylinositol 3 kinase delta (PI3Kδ) inhibitor, plus tislelizumab in patients with solid tumors.

BeiGene will also be presenting preclinical characterizations of several novel molecules from its internal discovery engine, including a CEA x 4-1BB bispecific antibody and a chimeric degradation activation compound (CDAC) targeting BTK, BGB-16673. Clinical data from an ongoing Phase 1 study of BGB-16673 in relapsed/refractory B-cell malignancies were presented at ASH (Free ASH Whitepaper) 2023, demonstrating clinical responses and a tolerable safety profile in heavily pre-treated patients with B-cell malignancies, including those with BTK inhibitor-resistant disease (NCT05006716).​

An additional preclinical presentation highlights the therapeutic potential of the triple-combination of tislelizumab with anti-LAG-3 (LBL-007) and anti-TIM-3 (surzebiclimab); this combination is being evaluated in an ongoing Phase 2 study in head and neck squamous cell carcinoma (NCT05909904).

BeiGene Presentations During AACR (Free AACR Whitepaper) 2024

Abstract Title

Abstract #

Presentation

Time (PDT)

Lead Author

Preclinical

Characterization of the correlation between BTK

degradation and tumor growth inhibition of the

BTK target protein degraders using PK/PD

modeling

2110

Monday, April 8

9 a.m. – 12:30 p.m.

Section 30

Board #1

Y. Wu

BGB-B167, a first-in-class 4-1BB/CEACAM5

bispecific antibody, exhibits potent in vitro and in

vivo anti-tumor activity and superior safety profile

in preclinical models

2371

Monday, April 8

9 a.m. – 12:30 p.m.

Section 38

Board #17

Z. Li

Translational assessment of triple combination

with tislelizumab (anti-PD-1), LBL-007 (anti-LAG-

3) and surzebiclimab (anti-TIM-3) highlights its

strong anti-tumor activity and clinical potential in

solid tumors such as HNSCC

4041

Tuesday, April 9

9 a.m. – 12:30 p.m.

Section 3

Board #17

H. Zhu

Clinical

Exploration of potential biomarkers correlated

with efficacy of ociperlimab (anti-TIGIT) plus

tislelizumab (anti-PD1) in 1L PD-L1+ non-small

cell lung cancer (NSCLC)

CT053

Monday, April 8

9 a.m. – 12:30 p.m.

Section 48

Board #3

S. Kim

A first in human, phase 1a, dose escalation study

of BGB 10188, a phosphatidylinositol 3 kinase

delta (PI3Kδ) inhibitor, + tislelizumab (anti-PD-1)

in patients with solid tumors

CT189

Tuesday, April 9

9 a.m. – 12:30 p.m.

Section 48

Board #17

R. Cosman

AdvanTIG-204: A phase 2, multicenter,

randomized, 3-arm, open-label study investigating

the preliminary efficacy and safety of ociperlimab

(anti-TIGIT) + tislelizumab (anti-PD-1) +

concurrent chemoradiotherapy (cCRT) in patients

with untreated limited-stage small cell lung cancer

(SCLC)

CT255

Tuesday, April 9

1:30 p.m. – 5 p.m. Section 48

Board #14

Y. Gong

BGB-A317-LBL-007-202 (NCT06010303): A

phase 2, randomized, active-controlled, open-

label study to evaluate the efficacy and safety of

LBL 007 (anti-LAG-3) in combination with

tislelizumab (TIS; anti-PD-1) plus chemotherapy

(chemo) as first-line (1L) treatment in patients

with unresectable locally advanced/metastatic

esophageal squamous cell carcinoma (ESCC)

CT274

Tuesday, April 9

1:30 p.m. – 5 p.m. Section 50

Board #4

S. Park

Liberty-201 (NCT05609370): Maintenance

fluoropyrimidine and bevacizumab with or without

anti-lymphocyte activation gene-3 (LAG-3)

antibody LBL-007 plus anti-programmed cell

death protein-1 (PD-1) antibody tislelizumab (TIS)

for patients (pts) with metastatic or unresectable

microsatellite stable (MSS)/mismatch repair

proficient (pMMR)colorectal cancer (CRC)

CT276

Tuesday, April 9 1:30 p.m. – 5 p.m.

Section 50

Board #6

H.-J. Lenz

BGB-LC-201 (NCT05635708): A phase 2, open-

label, multi-arm study of tislelizumab (TIS; anti-

PD-1) in combination with investigational agents

+/- chemotherapy as first-line treatment for

patients with locally advanced, unresectable, or

metastatic non-small cell lung cancer (NSCLC)

CT277

Tuesday, April 9

1:30 p.m. – 5 p.m. Section 50

Board #7

G. Blumenschein

About Tislelizumab

Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD‑1) monoclonal antibody with high affinity and binding specificity against PD‑1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

On March 6, 2024 Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, reported that management will host investor meetings at the Leerink Partners 2024 Global Biopharma Conference being held in Miami, FL from Monday, March 11 through Wednesday, March 13, 2024 (Press release, Vedanta Biosciences, MAR 6, 2024, View Source [SID1234640869]).

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On March 6, 2024 Syncromune, Inc., a clinical-stage biopharmaceutical company dedicated to the development of SYNC-T, an in situ platform combination therapy optimized for solid tumor cancers, reported that it will present late-breaking Phase 1 clinical data at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, being held in San Diego, California from April 5 to 10, 2024 (Press release, Syncromune, MAR 6, 2024, View Source [SID1234640868]).

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The presentation, titled, "Systemic responses to SYNC-T therapy: in situ personalized cancer vaccination with intratumoral infusion of multitarget immunotherapy in patients with metastatic castrate-resistant prostate cancer (mCRPC)," will include results from the SV-102 Phase 1 trial, and the therapy’s potential impact on the treatment landscape for metastatic castrate-resistant prostate cancer. This late-breaking presentation marks the first time that the Company will have publicly shared data from its clinical trials of the SYNC-T therapy platform.

Presentation Details are:

Title: Systemic responses to SYNC-T therapy: in situ personalized cancer vaccination with intratumoral infusion of multitarget immunotherapy in patients with metastatic castrate-resistant prostate cancer (mCRPC)

Presenter: Charles J. Link, M.D.

Date: April 7, 2024

Time: 3:00 – 5:00pm PT

Session Title: Cancer Vaccines: Ready for Prime Time?

Location: San Diego Convention Center, San Diego, California

On March 6, 2024 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next generation therapeutics for cancer patients, reported that the company will present preclinical data on its conditionally active immuno-oncology programs at upcoming scientific conferences (Press release, Sensei Biotherapeutics, MAR 6, 2024, View Source [SID1234640867]).

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Details of the company’s presentations are as follows:

Keystone Symposia’s Cancer Immunotherapy: Beyond Immune Checkpoint Blockade and Overcoming Resistance

Title: VISTA checkpoint targeting by SNS-101, a pH-selective antibody with enhanced safety and pharmacokinetic profiles, alters the tumor microenvironment and overcomes immune checkpoint inhibitor resistance
Presenter: Edward van der Horst, Ph.D., Chief Scientific Officer
Session: Progress in Drugging the TIGIT and VISTA Pathways
Date and time: Tuesday, March 19, 2024, 3 – 4:30 p.m. PT

Material from the presentation will also be presented in a poster at the conference, as detailed:
Poster Number: 3021
Session: Poster Session 3
Date and time: Wednesday, March 20, 2024, at 7:30 p.m. PT

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024

Title: Conditionally active CD28xVISTA bispecific antibodies induce myeloid-driven tumor-specific T-cell co-stimulation for improved cancer immunotherapy
Presentation Type: Poster Presentation
Session Category: Immunology
Session Title: Immune Modulation Employing Agonist or Co-Stimulatory Approaches
Date and Time: Tuesday, April 9, 2024, 1:30 p.m. – 5:00 p.m. PT
Location: Poster Section 3
Abstract Number: 5294

On March 6, 2024 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, reported results from a preclinical pharmacology study that validate the potential for its lead clinical compound, RZ358, to treat individuals with non-islet cell tumors (NICTs) that have uncontrolled hypoglycemia (Press release, Rezolute, MAR 6, 2024, View Source [SID1234640866]).

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Tumor hyperinsulinism (HI) may be caused by a variety of different tumor types, resulting in islet cell tumor hypoglycemia (ICTH) and NICTH. The Company previously reported on the successful use of RZ358 under its Expanded Access Program (EAP) to treat patients with insulin-producing pancreatic islet cell tumors (ICTs), or insulinomas, causing severe and uncontrolled hypoglycemia. The therapeutic potential of RZ358 in this setting was anticipated given that ICTH is mediated by insulin and that RZ358 is known to work at the insulin receptor to decrease excess insulin binding and activity. However, it was unknown if RZ358 would have utility in NICTH where hyperinsulinism is mediated by hormones such as insulin-like growth factor-2 (IGF-2) or its variants, which likewise cause hypoglycemia by binding to and activating the insulin receptor. To test this, the Company recently completed in vitro pharmacology studies to evaluate the impact of clinically relevant concentrations of RZ358 on insulin receptor activation by IGF-2, compared to insulin. This was tested at the relative concentrations of each ligand that activate the insulin receptor and are physiologically relevant in tumor HI caused by ICTH and NICTH, respectively. These experiments successfully demonstrated the ability of RZ358 to similarly blunt both IGF-2 and insulin-mediated insulin-receptor signaling, at levels of these ligands that are disease-relevant in humans.

"These data demonstrate proof of the ligand-agnostic mechanism of action of RZ358 and therefore validate its broad utility in treating hypoglycemia resulting from any form of hyperinsulinism, including expanded tumor indications," said Dr. Brian Roberts, Chief Medical Officer of Rezolute. "Coupled with known outcomes from our clinical trials in congenital HI and the positive outcomes seen with ICTH in our expanded access program, we are excited by the potential for RZ358 to provide dramatic therapeutic benefit to cancer patients who often have limited treatment options for managing serious and uncontrolled hypoglycemia, which can accompany their cancer and disrupt treatment plans."

The Company recently reported on its successful interaction with the U.S. Food and Drug Administration (FDA) in January 2024 regarding the potential to initiate a single registrational study in patients with hypoglycemia due to tumor HI. The Company will continue to evaluate the feasibility of a development program in this indication, with the possibility of including both ICTH and NICTH patients. The inclusion of NICTH patients in a potential addressable market for RZ358 in tumor HI would more than double the population. The Company is also currently evaluating RZ358 in a Phase 3 clinical trial in congenital HI, which is a rare pediatric condition where, similar to ICTH, children overproduce insulin creating a dangerous hypoglycemic state.

About Tumor Hyperinsulinism (HI)
Tumor HI may be the result of two distinct types of tumors: islet cell tumors (ICTs) and non-islet cell tumors (NICTs), both of which lead to hypoglycemia due to excessive activation of the insulin receptor. Insulinomas are the most common type of functional ICT and cause hypoglycemia because of over production of insulin. NICTs can cause hypoglycemia by producing and secreting insulin-like paraneoplastic substances such as IGF-2 or related variants that bind to and activate the insulin receptor. This form of hypoglycemia can occur in more than 15 different tumor types, 60 percent of which are malignant, including hepatocellular carcinoma. The total addressable market for the combined indications causing tumor HI is estimated to be approximately 4,500 patients in the U.S. alone, including approximately 1,500 with ICTH and 3,000 with NICTH. The unique mechanism of action of RZ358 to attenuate excess insulin receptor activation mediated by insulin and related substances makes the therapy a potential universal treatment for hypoglycemia resulting from any form of hyperinsulinism.

About RZ358
RZ358 is a fully human monoclonal antibody that works downstream from the pancreas and other sources of insulin or related paraneoplastic substances, and instead binds to a unique allosteric site on insulin receptors in the liver, fat, and muscle. The antibody counteracts excess insulin receptor activation by insulin and other effector substances (such as IGF-2), thereby improving hypoglycemia. Because RZ358 acts downstream from the pancreas at the insulin receptor, it has the potential to be universally effective at treating hypoglycemia due to congenital HI, regardless of the causative genetic defect, as well as acquired forms of HI such as those mediated by insulinomas (ICTs) and other tumor types (NICTs). RZ358 received Orphan Drug Designation in the United States and European Union for the treatment of congenital HI, as well as Orphan Drug Designation and Pediatric Rare Disease Designation in the U.S. In the Phase 2 RIZE study, participants with congenital HI ages two and older nearly universally achieved significant improvements in hypoglycemia across multiple endpoints, including the primary and key secondary endpoints planned for the sunRIZE study. At doses and exposures that are planned for the Phase 3 study, RZ358 was generally safe and well-tolerated, and resulted in median improvements in hypoglycemia exceeding 80%. Based on the RIZE clinical trial outcomes and the evidence of benefit in this serious condition with substantial unmet medical need, RZ358 was subsequently granted a priority medicines (PRIME) designation by the European Medicines Agency (EMA) and an Innovation Passport designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group for the treatment of congenital HI. RZ358 also received Orphan Drug Designation status in the European Union for the treatment of Insulinoma, the primary cause of ICTH.